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Completed

NCT Number: NCT01669434

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery

Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively.

Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively.

Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.

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Key information

Conditions

Hypotension on Induction

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation.
  • Above referral must be in anticipation of a non-cardiac, non-vascular surgery.
  • Must have been on ACE-Inhibitor therapy for at least six weeks.

Exclusion criteria

  • Hypotension (systolic blood pressure < 90 or diastolic blood pressure <60) at the time of preoperative evaluation
  • Uncontrolled Hypertension (systolic blood pressure > 150 or diastolic blood pressure > 95) at the time of preoperative evaluation
  • Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology)
  • Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)
  • Left Ventricular ejection fraction less than 40%
  • Clinical evidence of decompensated heart failure at the time of preoperative evaluation
  • End-stage renal disease
  • Organ transplant surgeries

Treatment and study plan

ACEI continuation

Drug

These chronic medications will be taken without interruption preoperatively.

Other names: quinapril, Accupril, perindopril, Aceon, ramipril, Altace, benazepril, Lotensin, captopril, Capoten, enalapril, Vasotec, fosinopril, Monopril, lisinopril, Prinivil, Zestril, trandolapril, Mavik, moexipril, Univasc

ACEI omission

Drug

Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.

Other names: quinapril, Accupril, perindopril, Aceon, ramipril, Altace, benazepril, Lotensin, captopril, Capoten, enalapril, Vasotec, fosinopril, Monopril, lisinopril, Prinivil, Zestril, trandolapril, Mavik, moexipril, Univasc

Primary outcomes

  1. Number of Participants With Interoperative Hypotension

    Time frame: During anesthesia, an expected average of 3 hours.

    Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)

Secondary outcomes

  1. Acute Renal Failure

    Time frame: Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.

    Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level

  2. Low Blood Pressure Subgroup

    Time frame: During anesthesia, an expected average of 3 hours.

    Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.

  3. Older Age Subgroup

    Time frame: During anesthesia, an expected average of 3 hours.

    Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg

  4. Postoperative Hypertension

    Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.

    Any systolic blood pressure greater than 180 mmHg.

  5. Postoperative Hypotension

    Time frame: Arrival in PACU to hospital discharge, an expected average of 4 days.

    Any systolic blood pressure less than 90 mmHg

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2012
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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